The Safety and Immunogenicity of Live Zoster Vaccination in Rheumatoid Arthritis Patients Before Starting Tofacitinib: A Randomized Phase II Trial
Patients with RA who started treatment with tofacitinib 2–3 weeks after being vaccinated against herpes zoster had similar varicella zoster virus (VZV)-specific humoral and cell-mediated responses to the live vaccine compared to patients who received placebo.
In this Phase 2 study, humoral and cell-mediated immune responses were evaluated before receipt of live zoster vaccine (LZV) and at 2, 6 and 14 weeks after vaccination, having been randomised to tofacitinib 5 mg BID or placebo, 2–3 weeks after vaccination. Six weeks after vaccination, the VZV-specific IgG geometric mean fold rise (GMFR) and the VZV-specific T-cell GMFR did not differ significantly between the tofacitinib and placebo groups.
Vaccination appeared to be safe in all patients except one lacking pre-existing VZV immunity, who developed cutaneous vaccine dissemination 2 days after starting tofacitinib. This resolved after tofacitinib discontinuation and antiviral therapy, but the case suggests that patients should be screened for prior immunity before receiving LZV, or that a longer gap between vaccination and the start of tofacitinib is needed.